Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment
Recruitment status was Recruiting
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Purpose
The aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Other: Neurological and neuropsychological consultation, MRI Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment |
- Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Characterize the clinical evolution of these subjects: escalation with appearance of an insanity (of type Alzheimer's disease or of another type: degenerations fronto-temporal, insanity with body of Lewy), stabilization even improvement. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict a stabilization or an improvement. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Improve the state of the knowledge on the origin of the confusions mnésiques isolated at the persons of fifty and more years old. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Determine if the ultra-premature diagnosis of MY at a stage where the hurts are still confined in the structures under - hippocampiques is possible. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Subject control
|
Other: Neurological and neuropsychological consultation, MRI
Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36
|
|
Experimental: 2
40 patients before hand include in a program
|
Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36
|
Detailed Description:
The syndrome of "amnestic Mild Cognitive Impairment" (aMCI) has been introduced for patients with intact activities of daily living, with a memory complaint and objective memory decline on neuropathological assessment, without significative change in other domains of cognition. Follow-up in these patients shows that the memory impairment may remain stable or improve, while it worsens or extends to other cognitive domains in others, indicating prodromal AD.
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients beforehand include in the PHRC 2001 study (These patients presented to the inclusion in the PHRC 2001 a qualified board of amnestic Mild Cognitive Impairment [aMCI] or light cognitive confusion of type amnestic)
- The patient must be affiliated to an insurance scheme disease to participate in this study
Exclusion Criteria:
- For the magnetic resonance imaging: usual contraindications for an examination by MRI: claustrophobia, metal foreign bodies, pacemakers, etc.
- Incapacitated to realize the neuropsychological evaluation because of medical intercurrentes disorders
- Appointment of a guardian
Contacts and Locations| Contact: Matthieu CECCALDI, MD | 49-138-5928 | mceccaldi@mail.ap-hm.fr |
| Contact: Mira DIDIC, MD | 49-138-5928 | mira.didic@medecine.univ-mrs.fr |
| France | |
| Hopital de la Timone- Service de neurologie et de neuropsychologie | Recruiting |
| Marseille, France, 13005 | |
| Contact: Matthieu CECCALDI, MD 49-138-5928 mceccaldi@mail.ap-hm.fr | |
| Contact: Mira DIDIC, MD 49-138-5928 mira.didic@medecine.univ-mrs.fr | |
| Principal Investigator: | Matthieu CECCALDI, MD | Assistance Publique des Hopitaux de Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique des Hopitaux de Marseille |
| ClinicalTrials.gov Identifier: | NCT00684281 History of Changes |
| Other Study ID Numbers: | 2007-A00851-52, 2007-27 |
| Study First Received: | May 21, 2008 |
| Last Updated: | January 29, 2010 |
| Health Authority: | France: Ministry of Health |
Additional relevant MeSH terms:
|
Alzheimer Disease Memory Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013